Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Observational study
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

OCRELIZUMAB

Medical condition to be studied

Multiple sclerosis
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Pregnant women

Estimated number of subjects

7035
Study design details

Main study objective

To estimate the frequency of pregnancy and infant outcomes in women with MS exposed to ocrelizumab in the 6 months before conception or during pregnancy. To compare the frequency of pregnancy and infant outcomes in the exposed cohort with that in pregnant women with MS unexposed to ocrelizumab (primary comparator) and pregnant women without MS unexposed to ocrelizumab (secondary comparator).

Outcomes

Spontaneous abortion, stillbirth, elective termination, preterm delivery, C-section, antenatal urinary tract infections, antenatal infections requiring hospitalization, major congenital malformations, minor malformations (to the extent available), small for gestational age, adverse effects on the infant immune system, infant growth and development (to the extent available)

Data analysis plan

Characteristics of the unmatched and matched cohorts, including frequency of outcomes, will be output. Balance in matching will be assessed by examining the distribution of variables in the cohorts and estimating standardized differences for each variable between the ocrelizumab-exposed and comparator cohorts. Variables with standardized differences above 0.1 will be further evaluated and may lead to a re-evaluation of the propensity score estimation. Unadjusted measures of outcome frequency will be estimated within the matched cohorts. Measures of association will vary across outcomes and include incidence rate ratios and odds ratios. No adjustment is planned beyond matching. Subgroup analyses will include strata of maternal age, calendar year, and others (depending on counts and data availability). Association results will be summarized across data sources using meta-analytic techniques with random effects.